Lorcaserin treatment for extended-release naltrexone induction and retention for opioid use disorder individuals: A pilot, placebo-controlled randomized trial.
Adult
Animals
Benzazepines
Buprenorphine
/ therapeutic use
Delayed-Action Preparations
/ administration & dosage
Female
Humans
Injections
Male
Methadone
/ therapeutic use
Middle Aged
Naltrexone
/ therapeutic use
Narcotic Antagonists
/ therapeutic use
Opioid-Related Disorders
/ drug therapy
Outpatients
Substance Withdrawal Syndrome
/ drug therapy
Swine
Clinical trial
Extended-release naltrexone
Induction
Lorcaserin
Opioid use disorder
Treatment
Journal
Drug and alcohol dependence
ISSN: 1879-0046
Titre abrégé: Drug Alcohol Depend
Pays: Ireland
ID NLM: 7513587
Informations de publication
Date de publication:
01 02 2021
01 02 2021
Historique:
received:
03
07
2020
revised:
23
11
2020
accepted:
27
11
2020
pubmed:
9
1
2021
medline:
12
5
2021
entrez:
8
1
2021
Statut:
ppublish
Résumé
Opioid Use Disorder (OUD) is a significant public health problem associated with severe morbidity and mortality. While effective pharmacotherapies are available, limitations exist with each. Induction onto extended-release naltrexone (XR-NTX) is more difficult than initiation of buprenorphine or methadone, even in inpatient settings, as it is recommended that patients remain abstinent for at least 7 days prior to initiating XR-NTX. The purpose of this trial was to determine if lorcaserin, a 5HT2c agonist, improves outpatient XR-NTX induction rates. An 8-week trial beginning with a brief detoxification period and induction onto XR-NTX. Sixty participants with OUD were enrolled in the trial, with 49 participants at the initiation of detoxification randomized to lorcaserin or placebo for 39 days. Additionally, ancillary medications were provided. The primary outcome was the proportion of participants inducted onto the first XR-NTX injection. Secondary outcomes were withdrawal severity (measured by COWS and SOWS) prior to the first injection and the proportion of participants receiving the second XR-NTX injection. The proportion of participants inducted onto the first (lorcaserin: 36 %; placebo: 44 %; p = .67) and the second XR-NTX injection (lorcaserin: 27 %; placebo: 31 %; p = .77) was not significantly different between treatment arms. Prior to the first injection, withdrawal scores did not significantly differ between treatment arms over time (treatment*time interaction COWS: p = .11; SOWS: p = .39). Lorcaserin failed to improve outpatient XR-NTX induction rates. Although this study is small, the findings do not support the use of lorcaserin in promoting induction onto XR-NTX or in mitigating withdrawal symptoms.
Sections du résumé
BACKGROUND
Opioid Use Disorder (OUD) is a significant public health problem associated with severe morbidity and mortality. While effective pharmacotherapies are available, limitations exist with each. Induction onto extended-release naltrexone (XR-NTX) is more difficult than initiation of buprenorphine or methadone, even in inpatient settings, as it is recommended that patients remain abstinent for at least 7 days prior to initiating XR-NTX. The purpose of this trial was to determine if lorcaserin, a 5HT2c agonist, improves outpatient XR-NTX induction rates.
METHODS
An 8-week trial beginning with a brief detoxification period and induction onto XR-NTX. Sixty participants with OUD were enrolled in the trial, with 49 participants at the initiation of detoxification randomized to lorcaserin or placebo for 39 days. Additionally, ancillary medications were provided. The primary outcome was the proportion of participants inducted onto the first XR-NTX injection. Secondary outcomes were withdrawal severity (measured by COWS and SOWS) prior to the first injection and the proportion of participants receiving the second XR-NTX injection.
RESULTS
The proportion of participants inducted onto the first (lorcaserin: 36 %; placebo: 44 %; p = .67) and the second XR-NTX injection (lorcaserin: 27 %; placebo: 31 %; p = .77) was not significantly different between treatment arms. Prior to the first injection, withdrawal scores did not significantly differ between treatment arms over time (treatment*time interaction COWS: p = .11; SOWS: p = .39).
CONCLUSIONS
Lorcaserin failed to improve outpatient XR-NTX induction rates. Although this study is small, the findings do not support the use of lorcaserin in promoting induction onto XR-NTX or in mitigating withdrawal symptoms.
Identifiants
pubmed: 33418204
pii: S0376-8716(20)30647-5
doi: 10.1016/j.drugalcdep.2020.108482
pmc: PMC7856237
mid: NIHMS1659565
pii:
doi:
Substances chimiques
Benzazepines
0
Delayed-Action Preparations
0
Narcotic Antagonists
0
Buprenorphine
40D3SCR4GZ
Naltrexone
5S6W795CQM
lorcaserin
637E494O0Z
Methadone
UC6VBE7V1Z
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
108482Subventions
Organisme : NIDA NIH HHS
ID : K24 DA029647
Pays : United States
Organisme : NIDA NIH HHS
ID : U54 DA037842
Pays : United States
Informations de copyright
Copyright © 2020 Elsevier B.V. All rights reserved.
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